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2011 - Meeting Annual U.S. FDA cGMP Training Requirement - Webinar By GlobalCompliancePanel

Date2011-10-05

Deadline2011-10-05

Venueonline tra, USA - United States USA - United States

KeywordscGMP Training Requirements,U.S. FDA ,21 CFR issues in 111,FDA , ISO compliance ,Annual Lesson Plan

Websitehttp://bit.ly/pYq0Fw

Topics/Call fo Papers

Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. "Business as usual" is unacceptable. Recently several once 'model' companies have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal cGMP compliance training to get 'in sync' with the FDA's shift in focus. Refine your training to address areas of known deficiencies and areas of special FDA concern. Use such to increase productivity. Start immediately.

Areas Covered in the Session:
Focus on key cGMP issues
Avoid complacency from past "good" FDA / ISO compliance
Developing the Annual Lesson Plan(s)
The major 21 CFR issues in 111, 210 / 211, and 820
Defect recognition
How to address known problem areas during cGMP training
Stop unauthorized changes -- Prove 'in control'
Monitor and maintain 'the edge'
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Last modified: 2011-09-15 16:33:48